OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00258375 |
Recruitment Status :
Completed
First Posted : November 24, 2005
Last Update Posted : August 4, 2023
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RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: custirsen sodium Drug: docetaxel | Phase 2 |
OBJECTIVES:
Primary
- Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response rate, in women with locally advanced or metastatic breast cancer.
Secondary
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and on days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on days 1 and 8 of all courses. Treatment repeats every 21 days* for up to 10 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 1 is 28 days in length and all subsequent courses (courses 2-10) are 21 days in length.
After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression.
PROJECTED ACCRUAL: Approximately 42 patients will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer |
Actual Study Start Date : | October 21, 2005 |
Actual Primary Completion Date : | February 23, 2007 |
Actual Study Completion Date : | September 22, 2008 |
- Objective response measured by RECIST criteria after accrual of 14 evaluable patients
- Toxicity
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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed breast cancer
- Metastatic or locally advanced disease
- Not curable with standard therapy
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Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
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Lesion must be outside of the previously irradiated field
- If the sole site of disease is in a previously irradiated field, there must be evidence of disease progression or new lesions in the irradiated field
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- No known CNS metastases
-
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- Absolute granulocyte count ≥ 1,500/mm^3
- PTT, PT, and INR normal
- No known bleeding disorder
Hepatic
- Bilirubin normal
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No significant cardiac dysfunction
Immunologic
- No active uncontrolled infection
- No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No preexisting neuropathy ≥ grade 2
- No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- No other serious medical condition or illness that would preclude study participation
- No significant neurological disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior trastuzumab (Herceptin^®) allowed
Chemotherapy
- Recovered from prior chemotherapy
- At least 6 months since prior adjuvant chemotherapy (taxanes allowed)
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At least 4 weeks since prior chemotherapy for advanced disease
- No prior taxanes for advanced disease
- No more than 1 prior chemotherapy regimen for advanced disease
- No other concurrent chemotherapy
Endocrine therapy
- At least 1 week since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
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At least 4 weeks since prior radiotherapy
- Low-dose, nonmyelosuppressive radiotherapy allowed within 4 weeks before study entry at the discretion of the investigator
- No prior radiotherapy ≥ 30% of functioning bone marrow
- No concurrent radiotherapy
Surgery
- At least 3 weeks since prior major surgery and recovered (wound healing must have occurred)
Other
- More than 4 weeks since prior investigational agents or new anticancer therapy
- No concurrent therapeutic anticoagulation therapy except low-dose oral anticoagulant therapy (i.e., 1 mg of oral warfarin once a day) or low molecular weight heparin
- No other concurrent investigational therapy
- No other concurrent cytotoxic therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258375
Canada, British Columbia | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
BCCA - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 |
Study Chair: | Stephen Chia, MD | British Columbia Cancer Agency |
Responsible Party: | NCIC Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT00258375 |
Other Study ID Numbers: |
I164 CAN-NCIC-IND164 ( Other Identifier: PDQ ) ONCOGENEX-OGX-011-06 ( Other Identifier: Oncogenex Technologies ) CDR0000450847 ( Other Identifier: PDQ ) |
First Posted: | November 24, 2005 Key Record Dates |
Last Update Posted: | August 4, 2023 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |